Kenz-Gelect Gel Pad
FDA 510(k) K820991 · Suzuken Co., Ltd.
510(k) numberK820991
Submission
- Device name
- Kenz-Gelect Gel Pad
- Applicant
- Suzuken Co., Ltd.
Mchenry, IL, US - Received
- April 8, 1982
- Decision date
- April 26, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K843731 | Kenz 80Z Mark IIDSI · Traditional | 07/11/1985SE |
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| K820854 | KENZ-45MDXN · Traditional | 06/01/1982SE |
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Questions and answers
When was Kenz-Gelect Gel Pad cleared by the FDA?
Kenz-Gelect Gel Pad (K820991) received a 510(k) decision of Substantially Equivalent on April 26, 1982, 18 days after the submission was received.
What is the product code of K820991?
The FDA product code is GYB – Media, Electroconductive, a Class II (moderate risk) device regulated under 21 CFR 882.1275.